ZINC OXIDE AND DIMETHICONE WITH DIMETHICONE- zinc oxide and dimethicone cream 
Galentic Pharma (India) Private Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Galshield Zinc Oxide / Dimethicone

Active ingredient        Purpose
Zinc Oxide (200 mg)      Diaper Rash
Dimethicone 1.8%         Skin Protectant

Purpose:

Warnings:

For external use only

Dosage and Administration:

For diaper rash

For poison ivy, oak and sumac

Other information

Inactive ingredients

Aloe Barbadensis Leaf Juice, Cetyl Alcohol, Cholecaliferol, Diazolidinyl Urea, Fragrance, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Purified Water, Retinyl Palmitate, Sodium Borate, Stearic Acid, Tocopheryl Acetate, Yellow 5, Yellow 6, Zea Mays (Corn) oil

Stop use if

Indications and Usage

Indications are for diaper rash and general skin protectant.

Do not use

Keep out of reach of children

Principal Display Panel

GalShield with Dimethicone

GalShield D.jpg

Galshield

ZINC OXIDE AND DIMETHICONE  WITH DIMETHICONE
zinc oxide and dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE18 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
CETETH-10 (UNII: LF9X1PN3XJ)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARETH-20 (UNII: L0Q8IK9E08)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
VITAMIN A (UNII: 81G40H8B0T)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-012-01113.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/08/2013
Labeler - Galentic Pharma (India) Private Limited (918531450)

Revised: 8/2013
Document Id: c824ad2f-391a-464f-a444-7b7d43d75038
Set id: 987f3500-e7b4-45bc-bb29-8b5b59b9bb4b
Version: 1
Effective Time: 20130809
 
Galentic Pharma (India) Private Limited